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Breaking News

July 30, 2015 - Greatbatch Inc., proposes a tax-free spin-off of its subsidiary, the QiG Group, into a medical device company, Nuvectra Corporation. In a Form 10 registration statement filed with the U.S. Securities and Exchange Commission, Greatbatch said neuromodulation industry veteran Scott Drees will be chief executive officer of Nuvectra; and Joseph A. Miller, Jr., PhD, its director and chairman of the board. (Globe Newswire)

July 30, 2015 - In a study funded in part by the National Institutes of Health, researchers in California and Russia have demonstrated the ability of five men with complete motor paralysis to make voluntary step-like movements after about 18 weekly sessions of noninvasive electrical stimulation to their spinal cord. The results, published in the Journal of Neurotrauma, reportedly represent the first time this voluntary motion was achieved using transcutaneous stimulation. The lead researcher was quoted as saying he is interested in finding if autonomic functions may also be enhanced with similar therapy, saying the studies seem to have reawakened some networks and could contribute to a clinical toolbox to aid patients by widening the selection of available therapies. (EurekAlert)

July 29, 2015 - An article summarizing a recent workshop on noninvasive neuromodulation says there is increasing interest from clinicians, patients, health systems, payers and industry. Although these devices may lead to more personalized care, the article says, their use could blurr the distinction between medical and non-medical approaches, which could potentially make it harder to develop an evidence base. (Medscape)

July 28, 2015 - A randomized controlled clinical trial reported in Anesthesiology showed a superior response rate for high-frequency spinal cord stimulation, compared to traditional, in back or leg pain among 171 study subjects at three months. The ratio of responders was 1.9 for back pain and 1.5 for leg pain. The authors report that the superiority was sustained through 12 months. (UPI)

July 28, 2015 - Co-authors who reviewed the charts of 50 patients who received sacral neuromodulation to treat neurogenic lower urinary tract dysfunction conclude that the treatment might be an additional therapy option in carefully selected patients. They report that 94% of the patients who received a permanent implant were either very satisfied or satisfied with the therapy. (Spinal Cord)

July 28, 2015 - A sham-controlled clinical trial of deep brain stimulation (DBS) to the ventral capsule and ventral striatum failed to show a significant difference in reduction of depression symptoms, according to results published in Biological Psychiatry. The clinical trial involved 30 patients. After 16 weeks, three of 15 patients (20%) responded to active stimulation, while two of 14 patients (14.3%) improved in the control group. Patients then entered a two-year open-label phase, in which the response rate was 20%, 26.7%, and 23.3% at 12, 18, and 24 months. The authors suggest that alternative study designs and stimulation parameters might be considered. (EurekAlert)

July 27, 2015 - International Neuromodulation Society member Simon Thomson, MBBS FRCA FIPP FFPMRCA, was quoted about the importance of early detection and a multi-disciplinary approach in an article about a patient with complex regional pain syndrome who received dorsal root ganglion stimulation for her condition. (The Guardian)

July 24, 2015 - Interim results were presented at the Alzheimer's Association International Conference regarding a Phase II clinical trial of patients with early Alzheimer's disease who were implanted with deep brain stimulation (DBS) systems targeting the fornix, a part of the memory circuit. Half of the 42 patients in the clinical trial did not have their DBS system turned on for the first 12 months. Results from the first year show similar changes in cognitive measures between the two groups. Evalulation of the two groups will continue for four years. The researchers said an examination of trends among subgroups, who showed differences in glucose metabolism, can inform the design of future clinical trials. (Medpage Today)

July 23, 2015 - In a "Beyond the Abstract" feature, authors say they found that sacral nerve stimulation that is guided solely by motor provocation during the implant procedure is more straightforward and requires less reprogramming, compared to procedures that include guidance from sensory feedback from patients. They encourage consideration of prospective studies to confirm those results. Their observational study appeared online in Neuromodulation: Technology at the Neural Interface in April. (Uro Today)

July 22, 2015 - Twenty patients who never had been treated for their infrequent migraine without aura were enrolled in a safety-and-efficacy trial of transcutaneous supraorbital neurostimulation. These patients used the device more than 2/3rd of the time expected and experienced fewer migraine attacks and migraine days, with most having a reduction in symptoms of at least 50%. (The Journal of Headache and Pain)

July 21, 2015 - A meta-analysis of clinical trials of transcranial direct current stimulation for neuropathic pain resulting from back injury indicated a moderate effect that was not maintained at follow-up. (Spinal Cord)

July 21, 2015 - A physiotherapy professor at the Graduate School of Health at the University of Technology Sydney is conducting clinical research into non-invasive brain stimulation for dystonia. She is comparing transcranial magnetic stimulation in neck dystonia and earlier results of transcranial direct current stimulation in patients who have hand dystonia. She anticipates later combining brain stimulation with more traditional physiotherapy treatments. (Brisbane Times)

July 20, 2015 - Ten daily sessions of repetitive transcranial magnetic stimulation reduced tinnitus symptoms in a randomized, blinded, placebo-controlled clinical trial carried out and funded by the Veterans Affairs Rehabilitation Research and Development Service in Portland, OR. The study involved 64 participants, half of whom received sham stimulation. The responder rate in the active stimulation group was 56% and in the sham stimulation group, 22%. The symptom improvement seen in the group that had active stimulation was sustained for 26 weeks, according to the researchers' paper in JAMA Otolaryngology – Head & Neck Surgery. (Pharmabiz.com)

July 2015 - A case report describes an effect on irritable bowel syndrome (IBS) that was noticed in a woman who received deep brain stimulation (DBS) to the anterior limb of the internal capsule for obsessive compulsive disorder. The patient reported substantial relief of her IBS symptoms after DBS. The authors noted in their report that "the reduction depended on specific stimulation parameters, was reproducible over time, and was not directly associated with improvements in obsessive compulsive disorder symptoms." (Clinical Gastroenterology and Hepatology)

July 16, 2015 - The FDA has approved St. Jude Medical's Invisible Trial System, which patients can control with an iPod Touch and clinicians can program and track with an iPad Mini. The wirelessly controlled trial spinal cord stimulation system includes a small external pulse generator. (Fierce Medical Devices)

July 15, 2015 - Mainstay Medical International plc announced issuance of two U.S. patents concerning its neurostimulation therapy for chronic low back pain. The company's device stimulates muscles in the lower spine to provide more control over these stabilizing muscles. (Business Wire)

July 15, 2015 - An article about a prototype neurostimulator-delivery tool in development by Cambridge Consultants says the Chimaera hand-held instrument is designed to be used in conjunction with a wearable optical device such as Google glass to provide the operator a visual overlay of the target area. It combines pre-operative 3D imaging and real-time sensing of nerves. (Reuters)

July 14, 2015 - Bioness, Inc. received clearance from the U.S. Patent Office for a patent claiming use of high-frequency stimulation with its implantable peripheral nerve stimulation device, StimRouter. The device is FDA-approved to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. (Business Wire)

July 13, 2015 - International Neuromodulation Society (INS) member Andre Machado, MD, PhD, was interviewed about his preclinical studies into the potential for deep brain stimulation to aid in stroke rehabilitation. INS member Konstantin Slavin, MD, was also quoted in the story about unanswered questions posed by the potential to translate the findings through possible future clinical trials. (Wall Street Journal)

July 11, 2015 - Researchers undertook a safety study of a novel approach to rehabilitation for foot drop in patients who had chronic impairment from stroke. They had nine study participants use an EEG cap while the peroneal nerve was stimulated. Over the course of 12 hour-long sessions, patients followed cues to flex or relax their foot. A post-hoc analysis suggests there was statistically significant, but not clinically significant, improvement of lower motor performance such as gait speed, walk distance and range of motion. (Journal of Neuroengineering and Rehabilitation)

July 9, 2015 - International Neuromodulation Society member Yun Guan, MD, PhD, and colleagues write that they have developed a simple simulation test bed that goes beyond existing models by including fundamental underlying sensory activity transmitted in dorsal column fibers. They say they have found so far that "interactions between stimulation-evoked and underlying activities are mainly due to collisions of action potentials and losses of excitability due to the refractory period following an action potential." (Cornell University Library)

July 9, 2015 - A study presented at the American Society of Clinical Psychopharmacology annual meeting in Miami indicates external trigeminal nerve stimulation may help alleviate symptoms of major depressive disorder. In the study, 43 patients were randomly assigned to active or sham treatment for six weeks. Patients wore electrode patches for eight hours at night. Data collected at six weeks showed that symptoms, and their severity, improved on average after six weeks in patients who had failed at least one antidepressant. The treatment was originally investigated for drug-resistant epilepsy, and later has been explored for potential efficacy in psychiatric disorders like depression, PTSD, and ADHD. (Medscape)

July 9, 2015 - A 4-year-old girl who was born without a cochlea and auditory nerve had an auditory brainstem implant at 23 months of age, and is making progress in understanding spoken language. (Daily Mail)

July 8, 2015 - A column recaps brain research into increasing responsiveness of patients who are in a minimally conscious state, including findings from investigations involving deep brain stimulation. (Wall Street Journal)

July 6, 2015 - Authors of a scholarly article propose that excess extracellular potassium may mediate some effects of deep brain stimulation, through affecting inhibition and excitation of cells and axons, thereby interrupting pathological activity. (The Neuroscientist)

July 7, 2015 - Helius Medical Technologies, Inc.'s NeuroHabilitation Corporation division has entered into a cost-sharing contract with the U.S. Army Medical Research and Materiel Command to support a clinical trial investigating the safety and effectiveness of the company's non-invasive Portable Neuromodulation Stimulator (PoNS™) for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The (PoNS™) device is placed on the tongue to stimulate cranial nerves that innervate muscles there. (Business Wire)

July 6, 2015 - Allergan of Dublin, Ireland will pay $125 million acquire South San Francisco-based Oculeve, a development-stage company that is developing a nasal neurostimulation device designed to increase tear production in patients with dry eye disease. The deal includes milestone payments for development of Oculeve's OD-01 neurostimulation therapy. Two pivotal trials are planned, with commercialization potentially occurring in 2017 after FDA approval, the company said. (Mass Device)

June 29, 2015 - Rhode Island has its first functional electrical stimulation bicycle, which can help prevent muscle atrophy in people with motor impairment. The bike was donated through a fund-raising drive begun by a spine-injury patient who had used similar equipment during his post-injury rehabilitation in Boston. (Providence Journal)

June 29, 2015 - A literature search for controlled trials of spinal cord stimulation in cancer-related pain did not identify new studies that had not already been included in a 2013 systematic review. Four case series that represented 92 patients were previously reported and found decreases in mean pain scores and analgesic use. (Cochrane Database of Systemic Reviews)

June 25, 2015 - Sorin Group and Cyberonics said when their merger is complete the new company will be named LivaNova. Its three business units in cardiac surgery, cardiac rhythm management and neuromodulation will have headquarters in Mirandola, Italy; Clamart, France; and Houston, Texas, respectively. (Mass Device)

June 25, 2015 - Duke University Professor of Biomedical Engineering Warren Grill, PhD received a $4 million Javits Neuroscience Investigator Award, which will support studies for up to seven years. His team is interested in potential benefits of varying deep brain stimulation pulse patterns in patients with Parkinson's disease. (The News & Observer)

June 24, 2015 - An investigational device that synchronizes low-field transcranial magnetic stimulation to a patient's alpha brainwave frequency was more effective than sham in achieving a clinical response in patients with major depressive disorder, according to a safety and efficacy study of more than 200 patients that was published in Brain Stimulation. Patients whose active stimulation treatment was both accurate and consistent had a 34.2% response rate, compared to a 8.3% response rate from sham stimulation. (Eurekalert)

June 18, 2015 - The Impact Factor of Neuromodulation: Technology at the Neural Interface continues to rise, and in 2014 rose from 1.785 to 2.701 -- almost one full point. The journal ranking in the Clinical Neurology category is now 76/192 (up from 122/194) and in the Medicine, Research & Experimental category it is 54/123 (up from 78/124). (Wiley Online Library)

June 2015 - The lateral hypothalamic area "remains the primary DBS target for treating obesity because the LHA is the central hub for all circuits involved in the drive to eat," write International Neuromodulation Society members Derrick A. Dupré, MD; Nestor Tomycz, MD, and colleagues in a review of past, present and future deep brain stimulation targets for obesity. (Journal of Neurosurgery)

June 12, 2015 - The U.S. FDA approved St. Jude Medical Inc.'s rechargeable Brio deep brain stimulation (DBS) system for management of medication-resistant motor symptoms of Parkinson's disease and essential tremor. The DBS system is the second to receive FDA approval, with Medtronic's Activa system approved in the U.S. in 1997 for essential tremor and in 2002 for Parkinson's disease. (FDA)

June 10, 2015 - The International Neuromodulation Society named its third Giant of Neuromodulation, selecting Clinatec Chairman Alim-Louis Benabid, MD, PhD, for the honor for his development of deep brain stimulation to treat Parkinson's disease and other disorders. (News-medical.net)

June 10, 2015 - Five abstracts were recognized in the International Neuromoduation Society's first best abstract competition at the12th World Congress in Montreal. The presentations ranged from clinical to basic science, such as a demonstration of a brain computer interface that permitted a man with tetraplegia to control his otherwise unresponsive hand, and a preclinical study that showed deep brain stimulation aided formation of new neural connections during stroke recovery. (News-medical.net)

June 10, 2015 - Children and adolescents who received deep brain stimulation for generalized dystonia maintained significant symptom relief for up to eight years, according to a study presented by Argentinean Neuromodulation Society President Juan Carlos Andreani, MD at the 12th World Congress of the International Neuromodulation Society. (News-medical.net)

June 10, 2015 - Mean annual healthcare expenditures increased in each of the three years before spinal cord stimulation treatment, and decreased in each of the three years after, according to a study based on data from the Vancouver Island Health Authority that was presented at the International Neuromodulation Society 12th World Congress. Hospital costs especially contributed to the overall expenditures. (Science Daily)

June 10, 2015 - The first publicly funded pilot study of spinal cord stimulation (SCS) has shown that therapy and trial outcome measures of SCS in refractory chronic angina pectoris were appropriate and feasible. International Neuromodulation Society member Sam Eldabe, MD, and collaborators in the multi-center study will advise NICE that a fully powered nationwide study is feasible under the U.K. definition of refractory chronic angina pectoris. The findings were presented at the International Neuromodulation Society 12th World Congress. (Newsmedical.net)

June 10, 2015 - At the International Neuromodulation Society 12th World Congress, new observational data from more than 300 patients show use of 3D neural targeting software provided 1.5 times better overall pain relief and 2 times better low back pain relief than a previous-generation spinal cord stimulation system. (Fierce Medical Devices)

June 9, 2015 - WISE Srl, which is developing next-generation neurostimulation leads, announced the closing of a EUR 3 million series A financing round, led by Principia SGR, an Italian Venture Capital firm. Existing investors High-Tech Gründerfonds, Atlante Seed and b-to-v Partners joined the round alongside with three new investors Atlante Ventures, F3F and Antares. (WISE Srl)

June 8, 2015 - Research findings reported at the International Neuromodulation Society 12th World Congress showed that stimulation of the dorsal root ganglion (DRG) provided significant pain relief in 81.2% of patients with chronic lower limb pain from complex regional pain syndrome or peripheral causalgia. The data were obtained in the ACCURATE study of 152 patients at 22 centers in the U.S. The study subjects were randomized to receive either DRG stimulation or traditional spinal cord stimulation (SCS) for three months. In the SCS group, 55.7% of patients achieved significant relief of their chronic lower limb pain, which has been difficult to treat with traditional SCS. (Business Wire)

June 8, 2015 - Neurosurgeons and engineers at NASA and the Mayo Clinic have collaborated on development of potential nanotechniques for future deep-brain-stimulation tools. The work was presented at the International Neuromodulation Society 12th World Congress. (Tech Times)

June 8, 2015 - Bioness, Inc. announced the commercial availability of StimRouter, its FDA-approved implantable neuromodulation device to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other therapies, such as medications. (Business Wire)

June 5, 2015 - Algostim, LLC, a subsidiary of Greatbatch, Inc.'s QiG Group, announced it will now do business as Nuvectra. The medical device company will commerciallze the Algovita spinal cord stimulation system to treat chronic intractable pain of the trunk and/or limbs. (NASDAQ)

June 5, 2015 - Boston Scientific announced the European launch of the Precision Novi™ spinal cord stimulation system at the 12th World Congress of the International Neuromodulation Society. The 16-contact primary cell (non-rechargeable) device has CE Mark approval for the treatment of chronic pain. (Newsmedical.net)

June 4, 2015 - St. Jude Medical, Inc. announced CE Mark approval and the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system that uses Apple™ iPod touch™ and iPad mini™ technology. The system consists of an external pulse controller, a patient iPod touch controller, and Bluetooth communication function that eliminates the programming trial cable. (Med Device Online)

June 4, 2015 - A collaboration between Battelle and the Feinstein Institute for Medical Research, the research arm of The North Shore-LIJ Health System, was announced in which Battelle plans to create a “neural tourniquet” device, based on science developed at the Feinstein Institute, to help staunch blood loss through electronic stimulation of neural pathways to the spleen, preparing the body for clotting in response to a wound. (Med Device Online)

June 4, 2015 - A five-year, $10 million grant from the National Institute of Mental Health establishes a new center at the University of Rochester to improve understanding of brain networks and their "hubs" that are key in obsessive compulsive disorder. The new Silvio O. Conte Center for Basic and Translational Mental Health Research includes mental health researchers at Harvard University, the University of Pittsburgh, the University of Puerto Rico, and Brown University. (University of Rochester)

June 4, 2015 - Researchers from Duke Medicine published in the journal Human Brain Mapping http://onlinelibrary.wiley.com/doi/10.1002/hbm.22836/abstract that they have created a high-resolution 3D map of the human brainstem to serve as a guide for deep brain stimulation, and to visualize complex neuronal connections. (Medical News Today)

June 4, 2015 - Researchers from the University of Washington are adding Bluetooth communication to the Medtronic Activa PC+S Deep Brain Stimulation system for an Android smartwatch app so that when an essential tremor patient senses a tremor, the patients can initiate stimulation using that handheld device. (University of Washington)

June 3, 2015 - A two-day NIH Brain Initiative workshop presented information on opportunities for collaborative partnerships between clinical/academic researchers and corporate manufacturers of devices for human brain modulation and recording. The workshop was organized to accentuate the need for a streamlined path for developing and integrating innovative new technologies. One purpose of the workshop was to describe a proposed NIH framework for facilitating and lowering the cost of new studies using these devices. A second purpose was to discuss regulatory and intellectual property considerations. The organizers are also soliciting recommended approaches for data coordination and access. (NIH)

June 1, 2015 - Members of the media were invited to a news briefing by the president of the Canadian Neuromodulation Society, Michel Prud'Homme, MD, PhD, immediately before a free public lecture on neuromodulation therapies, which was a local satellite event the weekend before the start of the International Neuromodulation Society 12th World Congress in Montreal. (Newsmedical.net)

June 1, 2015 - Cefaly Technology announced results of a new PET trial in 28 patients who have at least four migraines per month. The trial showed that the company's transcutaneous electrical nerve stimulation device, which is FDA-approved for use prior to migraine onset, returns normal metabolic activity to the areas in the brain, specifically the orbitofrontal cortex and rostral cingulate. (Pharmiweb.com)

May 26, 2015 - Researchers in France published in Science Advances http://advances.sciencemag.org/content/1/4/e1400251 about potential high-performance transistors for bioelectronic devices, that tune transconductance (to amplify brain signals) through channel thickness rather than electrode surface area. The organic electrochemical transistors use conductive polymers and liquid electrolytes, materials that could form an interface between the brain and conventional silicon electronics. (IEEE Spectrum)

May 28, 2015 - StimGuard LLC announced two patients who received injectable tibial stimulators in August 2014 for overactive bladder have ongoing reduction of voiding episodes and more than 80% relief. The treatment is carried out at night using a sock to cover the stimulation area. The wirelessly powered implant delivers stimulation that the company said enables the brain to remap specific urge signals in a fashion similar to acupuncture, but permanent. The company plans to complete regulatory studies for CE Mark in 2015 and seek FDA approval in 2016. (Business Wire)

May 21, 2015 - An article describes a phrenic-pacing development by Lungpacer Medical Inc., saying the innovation will be presented during a preconference of the International Neuromodulation Society 12th World Congress. The device is under development for patients who depend on mechanical ventilation, and is designed to stimulate the diaphragm of critically ill patients to contract in order to aid their recovery. (Vancouver Sun)

May 22, 2015 - International Neuromodulation Society President-Elect Timothy Deer, MD, in an interview on FindaTopDoc radio, described the development and growth of neuromodulation therapy, noting how innovation is a collaborative effort that is allowing a widening number of patients to benefit. (BlogTalkRadio)

May 22, 2015 - Researchers from Caltech and the University of Southern California Keck School of Medicine reported in Science about a clinical trial in which a man paralyzed for more than 10 years was able to intentionally move a robotic arm controlled through two implanted neural arrays on his posterior parietal cortex. (Medical Xpress)

May 21, 2015 - A poster at the International Headache Congress in Valencia, reports on a survey in which 49 respondents explained their attitude to electroCore’s non-invasive vagus nerve stimulation treatment for migraines. Respondents were allowed to cite more than one reason. The most-cited reason for starting the therapy (67.3%) was resistance to standard migraine therapy. The most-cited reason for continuation (69.5%) was efficacy. After treatment, 46% of attacks were minimized or halted after two hours, and 61% after four hours. (Briefing Wire)

May 20, 2015 - Axonics Modulation Technologies, Inc. announced that it has been selected to present its technology advancements during the Innovations in Neuromodulation session at the International Neuromodulation Society's 12th World Congress on June 6th in Montreal. The company makes an implantable sacral neuromodulation system to manage chronic intractable urinary and fecal dysfunction. The system has a rechargeable implantable pulse generator designed to be small and long-lasting. (Business Wire)

May 20, 2015 - Helius Medical Technologies has completed enrollment for its pilot clinical trial at the Montreal Neurological Institute in which 14 patients with multiple sclerosis will be treated for balance and gait symptoms over the course of 14 weeks, undergoing a physiotherapy protocol combined with noninvasive stimulation of cranial nerves using the Portable Neuromodulation Stimulator (PoNS™). (Business Wire)

May 19, 2015 - Health Canada approved St. Jude Medical's Prodigy™ spinal cord stimulation system with burst technology, the company announced. The first Canadian patient was implanted with the system earlier this month by Ivar Mendez, M.D., Ph.D, FRCSC, FACS at Saskatoon Health Region’s Royal University Hospital. (Market Watch)

May 14, 2015 - Deakin University reported in the Journal of Neuropsychology http://onlinelibrary.wiley.com/doi/10.1111/jnp.12070/abstract that repetitive transcranial magnetic stimulation sessions helped reduce symptoms of Mal de debarquement syndrome in six out of seven patients. Now the researchers hope to receive funding to expand the clinical trial. (Herald Sun)

May 13, 2015 - Researchers at Washington University in St. Louis have received a three-year, nearly $1.9 million grant from the Defense Advanced Research Projects Agency (DARPA) for a preclinical study to explore stimulating sensory nerves to add a sense of touch to prosthetic hands. (Newswise)

May 14, 2015 - The International Neuromodulation Society issued a news release about the 12th World Congress abstracts that cover device innovation, expanding indications, and evidence of important outcome measures. Scientific Program Chair and President-Elect Dr. Timothy Deer is quoted as saying neuromodulation is viewed as a new treatment paradigm. (Newswise)

May 14, 2015 - A poster presentation at the International Headache Congress in Valencia, Spain reports that vagus nerve stimulation (VNS) inhibits cortical spreading depression (CSD), which is known to be the cause of migraine aura and a trigger for headache. Both invasive and noninvasive VNS were equally effective, and stimulation of less than 30 minutes reduced CSD for more than three hours, more quickly than prophylactic pharmaceutical migraine treatments. (electroCore)

May 14, 2015 - The University of California Davis Health System announced a clinical trial of a deep brain stimulation (DBS) approach that may limit cognitive decline in patients with Parkinson's disease. The approach involves DBS of the subthalamic nucleus (STN) using low-frequency theta stimulation targeting an isolated portion of the STN involved in cognition. The study will involve detailed before-and-after tests of memory, learning and rule use. (Health Canal)

May 14, 2015 - The Magstim Company Ltd. of Wales announced it has received FDA 510(k) clearance to market its Magstim Rapid2 Therapy System, a repetitive transcranial magnetic stimulation system, for the treatment of drug resistant Major Depressive Disorder in the United States. (Magstim)

May 11, 2015 - Privately held StimGuard announced the FDA has approved the start of a clinical trial to evaluate a micro-sized device for overactive bladder (OAB) that can be placed completely through a needle. The announcement says the implant is wirelessly powered by an external, "electroceutical" microchip from Stimwave, a company founded by StimGuard's co-founder, which delivers small pulses of energy to electrodes near surrounding nerves. The StimGuard-device clinical trial is due to start in the U.S. in the summer of 2015. (Business Wire)

May 12, 2015 - Autonomic Technologies, Inc. announced it has received a series D round of financing that raised $38 million. The company said it will use the money to expand its marketing in Europe of Pulsante™, its microstimulator to treat severe headaches, and to fund an ongoing clinical study of the device in the U.S. to treat chronic cluster headache. Pulsante™ has received CE mark approval in Europe for treatment of cluster headache. (Military Technologies)

May 11, 2015 - Nevro Corp. said Boston Scientific Corporation has filed two petitions at the U.S. Patent Office for inter partes review of claims that were previously granted to Nevro. A inter partes petition challenges patent claims based on prior art and publication. (CNN Money)

May 11, 2015 - ImThera Medical said the first two patients with obstructive sleep apnea were implanted with its aura6000 system in its U.S. clinical study. ImThera's device has received CE Mark approval in Europe, and is commercially available in some markets outside the U.S. (Mass Device)

May 8, 2015 - A research team including International Neuromodulation Society member Bengt Linderoth, MD, PhD, has published in Science Advances a proof-of-concept demonstration in laboratory mice of an implantable organic electronic device for neuropathic pain treatment. The implantable device releases the inhibitory neurotransmitter GABA (gamma-aminobuyric acid) into the intrathecal space, electrically controlling the release of this positively charged molecule through by applying a current to drive it through an ion-screening electrophoretic gel in the device distribution channel. (IEEE Spectrum)

May 8, 2015 - The FDA has approved the Senza system, Nevro Corp.'s spinal cord stimulation device that relieves trunk or limb pain without paresthesia. The company said in announcing the approval that the FDA is not restricting patients receiving the therapy from operating motor vehicles, that the system has 3T-conditional MRI compatibility, and received "superiority" labeling from the FDA. The FDA based its approval on a clinical study that showed 75% of patients treated had their chronic pain reduced by 50% within three months. Implant site pain and device lead dislocation were among the adverse events reported. (PR Newswire)

May 8, 2015 - International Neuromodulation Society member Christopher Honey, MD, was described as the only neurosurgeon in British Columbia who performs deep brain stimulation (DBS), in an article about a woman with multiple sclerosis whose DBS surgery to control the tremor of multiple sclerosis was documented by the news team. (Global News)

May 7, 2015 - The International Neuromodulation Society announced two preconferences of the 12th World Congress, an Innovation Day and a daylong set of talks on Mechanisms of Action, on June 6 and 7 respectively -- as well as the Canadian Neuromodulation Society's free public lecture on neuromodulation the afternoon of June 6. (Business Wire)

May 7, 2015 - The University of Texas Southwestern Medical Center in Dallas will be one of three sites to offer enrollment in a clinical trial of MicroTransponder Inc.'s vagus nerve stimulation system, Vivistim®, during post-stroke rehabilitation of arm function. (News-Medical.net)

May 6, 2015 - Researchers report a first-in-human, sham-controlled study of transcutaneous electrical vagus nerve stimulation in 40 patients who planned to undergo ablation for atrial fibrillation. After following the patients for several months, they say the results support the emerging paradigm of using neuromodulation to manage drug-refractory atrial fibrillation, which is attract for being nonpharmacological and nonablative. In 20 patients in the treatment arm, the study authors used a metal clip on the right ear to apply low-level stimulation to the auricular branch of the vagus nerve at the tragus. (Cardiac Rhythm News)

May 6, 2015 - A Canadian woman whose multiple sclerosis lead to disabling tremors received a deep brain stimulation implant that will be turned on in June. She said already her symptoms have lessoned now that the electrodes are in place. (Muskokaregion.com)

May 6, 2015 - A paper presented at the American Association of Neurological Surgeons annual meeting, based on a retrospective analysis of 762 patients, appears to support earlier findings that spinal cord stimulation efficacy is inversely proportional to the wait time. (Healio)

May 6, 2015 - Intraoperative monitoring during spinal cord stimulation implantation can help verify accurate placement of the leads, according to a paper presented at the American Association of Neurological Surgeons annual meeting. The prospective study of 73 patients indicated that electromyography in particular may help streamline programming by indicating which contacts may be ideal. (Healio)

May 6, 2015 - An analysis of 350 patients at 36 centers in the St. Jude Medical EMP3OWERTM study indicates that tailoring lead type, number, and targeting of stimulation area improved clinical outcomes and correlated with increased odds of decreased opioid usage, according to a presentation at the American Association of Neurological Surgeons annual meeting. (Healio)

May 6, 2015 - Researchers at Martinos Center for Biomedical Imaging at Massachusetts General Hospital reported using conductive polymers for novel potential neurostimulation leads that, through a similar radio-frequency interaction used to cloak some stealth aircraft, break up induced current, leading to less heating under magnetic resonance imaging conditions, according to tests with standard gel-filled models. They say the resistive tapered stripline technology reduces MRI-induced heating and allows use of higher-Tesla imaging systems. (The Engineer)

May 4, 2015 - St. Jude Medical announced it has completed acquisition of Spinal Modulation, Inc. The acquisition was completed on May 1. Spinal Modulation developed the Axium™ spinal cord stimulation system. That system has approval in the European Union and Australia. Results of a U.S. clinical trial, ACCURATE, will be presented at the International Neuromodulation Society 12th World Congress in June in Montreal, according to the company's announcement. (Business Wire)

May 4, 2015 - A young man who has both obsessive compulsive disorder (OCD) and autism was treated for his severe, disabling OCD symptoms with deep brain stimulation (DBS). International Neuromodulation Society member Robert Buchanan, MD, said this case is the first in which a patient with that dual diagnosis has received DBS. He said it seems to help the brain's intrinsic rhythms of electrical activity become more normalized. The patient, who sought treatment two years ago, said he is more focused and interactive as a result. Researchers at Seton Brain and Spine Institute in Austin, Texas hope to focus on on why DBS worked, and whether it can help autism patients live fairly normal lives as well, the news coverage says. (KHOU)

To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.

How Has Neuromodulation Been Developed and Used?

Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.

Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.

Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:

If you are not a medical professional and you are searching for information about neuromodulation and how these types of treatment could benefit a specific condition such as treatment-resistant headache or other chronic pain syndromes, you may find the sections titled Therapies, About Neuromodulation or FAQsparticularly helpful.

The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.

Neuromodulation: Technology at the Neural Interface contains articles of the highest scientific caliber. The journal's sole purpose is to advance the basic and clinical science of the field of neuromodulation. In eight issues a year, it publishes scientific works, scientific reviews, and abstracts of papers accepted for review at national and international congresses.